WRAPUP 1-US sees death concern in schizophrenia drugs

Fri Apr 3, 2009 8:34pm BST
 
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* AstraZeneca, Lundbeck drugs raise concerns-US FDA

* Drugs to be reviewed by FDA panel next week

* Both companies shares' fall 3 percent

By Lisa Richwine

WASHINGTON, April 3 (Reuters) - U.S. regulators are concerned about a potential risk of sudden death with schizophrenia drugs from AstraZeneca Plc (AZN.L) and H Lundbeck A/S (LUN.CO), documents released on Friday showed.

Danish drugmaker Lundbeck is seeking U.S. approval to market Serdolect, a schizophrenia drug sold in Europe, while AstraZeneca has applied to more widely promote its approved blockbuster schizophrenia treatment Seroquel XR for patients with depression and anxiety.

Lundbeck's drug was up for Food and Drug Administration review in 1998 when the company's partner at the time, Abbott Laboratories Inc (ABT.N), withdrew its application for approval amid fears that the drug might cause heart problems.

In a memo released on Friday, the FDA's director of psychiatry drugs said cardiac effects still raise questions about the drug's safety.

"There remains ... a concern about a possible risk of sudden cardiac death with this drug," Dr. Thomas Laughren wrote in a March 10 memo.  Continued...

 

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